Cleared Traditional

PROXIMATE DISPOSABLE SKIN STAPLERS (K820811) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820811 · Ethicon, Inc. · General & Plastic Surgery device
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Aug 1982
Decision
150d
Days
Class 2
Risk

K820811 is an FDA 510(k) clearance for the PROXIMATE DISPOSABLE SKIN STAPLERS. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on August 20, 1982 after a review of 150 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4740 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K820811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date August 20, 1982
Days to Decision 150 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 115d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAG Stapler, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4740
Definition A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAG Stapler, Surgical

All 41
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K820811.
AEON™ Endoscopic Powered Stapler
K251482 · Lexington Medical, Inc. · Jul 2025
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
K243596 · Intuitive Surgical, Inc. · Mar 2025
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND)
K240881 · Covidien (Part of Medtronic) · Nov 2024
ECHELON 3000 45mm Compact Stapler (ECH45C)
K241629 · Ethicon Endo-Surgery, LLC · Jul 2024
AEON Endoscopic Powered Stapler (Short/AEPH060)
K234039 · Lexington Medical, Inc. · May 2024
GIA™ Stapler with Tri-Staple™ Technology
K231934 · Covidien · Oct 2023